Is there an active Mutual Recognition Agreement (MRA) between the EU and USA?

If a site in the US performs packaging and labelling of an investigational medicinal product then ships this product into the EU for a clinical trial, will someone from the EU receiving company want to audit the US packaging site?

Can clinical trials materials be shipped to an investigator site before QP certification has been given?

Does the QP routinely review all documentation supporting a batch before certifying it?

What is meant by the term “eligible” to act as a QP?

Does a QP need to be a full time, permanent employee at a site?

What is the difference between the European Union (EU) and European Economic Area (EEA)?

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About Sue Mann Consultancy Ltd (SMC)

Sue Mann is the founder and Managing Director ofSue Mann Consultancy Ltd. Sue is a very experienced, energetic, highly effective QA professional working in the Pharmaceutical Industry, who over the years has achieved many significant improvements in both quality and compliance through the introduction of sound, pragmatic practices.

SMC Ltd provides advice and support in all areas of Pharmaceutical Quality and GMP, to help organisations operate effective and compliant Quality Management Systems.

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